The valsartan recall "may have been associated with adverse unintended clinical effects of controlled hypertension," according to research published Nov. 11 in Circulation and will be presented during AHA 2019 in Philadelphia, PA. Cynthia A. Jackevicius, BScPhm, PharmD, MSc, FACC, looked at patients 65 years or older who had been given a supply of at least one recalled valsartan product in Canada up until July 9, 2018 the recall date of six generic valsartan products. Diovan -- the brand name version of valsartan -- has not been recalled. Since last summer, the FDA has issued a number of recalls of certain generic valsartan medications, which is used to treat high blood pressure and heart failure, after detecting trace amounts. The pharmacist may be able to provide you with an unaffected ARB made by another company. Patients and health care professionals should report any unexpected adverse event with ARB-containing products to the FDAs MedWatch program to help the agency better understand the scope of the problem: An official website of the United States government, : Queens of the Stone Age will bring Phantogram, Viagra Boys, the Armed, and Savages' Jehnny Beth on their fall North American tour. If you are taking any medication containing an ARB, compare the information on your prescription bottle with the recall list to determine if your current medicine has been recalled. This resulted in recalls of various products and has likely had downstream effects Clipboard, Search History, and several other advanced features are temporarily unavailable. The first recall was in July 2018 when China's Zhejiang Huahai Pharmaceuticals recalled batches of valsartan for trace amounts of NDMA. ", Do Not Sell or Share My Personal Information. Since there are many manufacturers of valsartan and sources can vary whenever a patient refills a prescription, it is very likely that a patient using valsartan for four years would not have always received one of the relatively few affected medicines that contained these impurities. The results of this study indicate the valsartan recalls that occurred in 2019 did not significantly impact the clinical outcomes of the studied population. Moderately clinically significant. Torrent Pharmaceuticals expands its valsartan recall. Other blood pressure drugs have been recalled over concerns they also contain trace amounts of NDEA. La Operacin Deluxe tiene mucho -o todo- que ver con el final de Slvame, previsto para el prximo viernes 23 de junio. Teva Pharmaceuticals USA Inc. labeled as Actavis Pharma, Inc. Teva Pharmaceuticals USA Inc. labeled as Major Pharmaceuticals, FDA. Retrieved from. "We hope that today's approval of this new generic will help reduce the valsartan shortage, and we remain committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes for existing and future products," Gottlieb said. Hetero Labs, Inc., labeled as Camber Pharmaceuticals, Inc. NuCare Pharmaceuticals Inc. (Prinston/Solco), Preferred Pharmaceuticals, Inc., labeled as Solco Healthcare, Amlodipine/Valsartan/Hydrochlorothiazide (HCTZ) 10mg/320mg/25mg Tablet, Rising Pharmaceuticals Inc., labeled as Acetris Health, LLC (Aurobindo), Amlodipine/Valsartan/Hydrochlorothiazide (HCTZ) 5mg/160mg/12.5mg Tablet, Amlodipine/Valsartan/Hydrochlorothiazide (HCTZ) 10mg/160mg/12.5mg Tablet, Amlodipine/Valsartan/Hydrochlorothiazide (HCTZ) 10mg/160mg/25mg Tablet. The information on ConsumerSafety.org is provided for informational purposes only and is not intended to provide specific legal advice. National regulatory bodies should take immediate steps to ensure the provision of correct information to healthcare providers and the general public, which in this case seemed to be missing in various countries. If youre taking a blood pressure medication that was recently recalled, do not stop taking it. Those voluntary recalls came after the discovery of the chemicals NDMA and NDEA -- both probable human carcinogens -- at levels far above what the FDA considers an acceptable daily intake. Lawyers are filing valsartan lawsuits on behalf of people who were diagnosed with cancer after taking valsartan for more than a year or who suffered liver or kidney injuries that required an emergency room visit or hospital stay. Conflict of interest statement: The authors declare no conflicts of interest in preparing this article. The letter described how Zhejiang Huahai follows a specific route of synthesis using N,N-dimethylformamide, which could lead to the formation of NDMA as an impurity.20 In continuation to this, the EMA on 10 August stated that low levels of NDMA had also been detected in the valsartan-active substance manufactured by a second company, Zhejiang Tianyu, Taizhou, China.21 This declaration from both firms and EMAs latest review raised further questions on the safety of valsartan manufactured by various other manufacturers. If the pressure is too high, theres a risk that the heart will work too hard. : To date, none of the manufacturers have received any reports of people who use these medications becoming ill. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Graham Head, 66, who kidnapped and tried to rape two women, was caught after one victim remembered three digits of his car registration. Retrieved from, U.S. Food and Drug Administration. FDA has posted a list of currently available ARBs and the status of our assessment of those medications. Contact your doctor if you experience signs and symptoms of low blood pressure such as dizziness, lightheadedness, fainting, flushing, headache, or a rapid pulse or heart rate. If you would like to speak with a Drugwatch representative, please call 888-645-1617, "Drugwatch opened my eyes to the realities of big pharmacy. Napumpujte ho antioxidantmi a vitamnmi! In the latest case, detailed on Monday, Torrent Pharmaceuticals Limited expanded its voluntary recall for losartan potassium tablets and the combination medication, losartan potassium/ hydrochlorothiazide tablets. US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). Grapefruit can raise the levels of sildenafil in your body and delay the time it takes for the medication to work. U.S. Food and Drug Administration. Because ARBs treat serious medical conditions, continue taking your current medicine until a doctor or pharmacist gives you a replacement or a different treatment option. Drugwatch.com doesnt believe in selling customer information. As of 2022, the recall now includes some lots of other drugs in the same class as valsartan called angiotensin II receptor blockers (ARB) after manufacturers found N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) in some of these drugs in March 2019. The recalled medications include specific lots of losartan, irbesartan, valsartan and combination drugs with valsartan. MeSH terms Aged Aged, 80 and over Angiotensin Receptor Antagonists / therapeutic use During its investigation, the agency identified two possible carcinogens in valsartan medications. In her role at ConsumerSafety.org, Dr. Moncivais works alongside the writing and research staff to help deliver fact-based news stories to consumers. All rights reserved. January 25, 2019. 2023 Jun;79(6):849-858. doi: 10.1007/s00228-022-03439-3. What are valsartan, losartan, and irbesartan? Manufacturers recalled numerous lots of losartan medications. Additionally, contact your local pharmacist or the drug manufacturer for information about the proper disposal of recalled valsartan. The study included patients with essential hypertension, prescribed valsartan from a lot number that was recalled as of 1 March 2019, and mailed a recall letter on 12 March 2019. Blood Press Monit. Federal government websites often end in .gov or .mil. Our team includes experienced medical writers, award-winning journalists, researchers and certified medical and legal experts. Should I continue taking my medication even if it has been recalled? Chemical impurities discovered in angiotensin receptor blocker (ARB) products in late 2018-2019 resulted in recalls of various products and has likely had downstream effects for patients and prescribers. In the world of regulatory sciences, such incidents are common and observed by many drug substance manufacturers during routine and stress testing and even after marketing of the product during real-time stability and postmarketing analysis. The agency estimated that the tainted drugs first entered the US market around 2014. Careers, Unable to load your collection due to an error. A total of 33 medication changes involving valsartan occurred, with approximately one-third being changed to another ARB (n = 11) or drug class (n = 12). Today, many valsartan medications remain on the FDA's list of drug shortages. U.S. Food and Drug Administration. The FDA says that the risk of harm to someones health may be higher if one of these medications is stopped immediately without any alternative treatment.. Statement on the agencys ongoing efforts to resolve safety issue with ARB medications. As with the valsartan and losartan recalls in 2018 and 2019, the FDA has advised people on recalled quinapril to continue the medication until their doctor or pharmacist can identify a replacement . Inclusion in an NLM database does not imply endorsement of, or agreement with, the contents by NLM or the National Institutes of Health. ARB,, MeSH 11 Canada Government. A total of 300 patients meeting eligibility criteria were included. Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets . Losartan, a blood pressure medication in the angiotensin II receptor blocker (ARB) class, helps reduce blood pressure by preventing blood vessels from narrowing or constricting. See if your valsartan is on the list of recalls. Retrieved from, Graedon, J. NDMA 96 nanograms per day; 0.3 parts per million, NDEA 26.5 nanograms per day; 0.083 parts per million, NMBA 96 nanograms per day; 0.3 parts per million, Amlodipine, valsartan and hydrochlorothiazide (HCTZ), A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco). Helped more than 12,000 people find legal help. Tests are selected based on assessments of what impurities may develop based on the manufacturing process. If you cannot find information on the FDAs website, talk to your pharmacist. This means expired valsartan drugs could still be problematic if somebody uses them. Similar to NDMA, the chemical could possibly cause cancer. Antihypertensive medication changes and titrations were also characterized post-recall. 0:13. . 2016 Jul;57(7):384-9. doi: 10.11622/smedj.2016040. The FDA website provides lists of valsartan products under recall, . U.S. Food and Drug Administration. In early November, another blood pressure drug, irbesartan, was recalled, followed in mid-November by . Retrieved from, Health Canada. Medications containingonly amlodipine or hydrochlorothiazide (HCTZ) are not being recalled. This website and its content may be deemed attorney advertising. HHS Vulnerability Disclosure, Help Return it to your pharmacist when you get your new medication. Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Minden, 11800, Malaysia. Recall of five valsartan-containing pharmaceutical products [press release]. Technical Fact Sheet NDMA. government site. ALL RIGHTS RESERVED. The site is secure. A list of ARB medications affected by the recall are available on FDAs website for healthcare professionals and patients to monitor. May-2019: 0591-2167-19: Valsartan 40MG Tablets, USP 90 Count: 1268429A: Oct-2019: This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Blood pressure endpoints were collected 6 months before (pre-recall) and after the recall letter was mailed (post-recall). You may also be eligible for a refund. FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications. You may also be able to get valsartan from a manufacturer that is not on the recall list. The recall does not currently include the brand name valsartan-containing drugs Diovan, Entresto, Exforge, and Exforge HCT. So far, in addition to the valsartan-containing products, the recall also includes certain losartan and irbesartan products as well, according to an FDA questions and answers page. Updated December 12, 2018. Having a family member with major depression and anxiety, I was looking for information on her medications. Available for Android and iOS devices. Since last summer, the FDA has issued a number of recalls of certain generic valsartan medications, which is used to treat high blood pressure and heart failure, after detecting trace amounts of the cancer-causing chemical N-nitrosodimethylamine (NDMA). August 28, 2019. Ashley Welch covers health and wellness for CBSNews.com, First published on March 13, 2019 / 12:29 PM. Ask your doctor about your treatment options. "The US Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure," the FDA press release read. In one year, the FDA recalled more than 600 generic valsartan medications due to contamination. She focuses on various medical conditions, health policy, COVID-19, LGBTQ health, mental health and womens health issues. The new testing method detects both NDMA and NDEA. The site is sponsored by law firms. Lists of ARB medicines affected by the recall are available on FDAs website for healthcare professionals and patients to monitor. People began filing Zantac cancer lawsuits shortly after the recall. / CBS News. Join our newsletter to stay up to date on dangerous drugs and devices, keep up on lawsuit and settlement news, learn about FDA recalls, and more. Over the past year, the FDA has recalled multiple blood pressure medications from several manufacturers after discovering potential carcinogens in some batches. Recalls have only involved generics of the drug, not the brand name Diovan. Manufacturers may sell drugs containing the impurities as long as the levels of the impurity remain within the FDA's published intake levels. Retrieved from, U.S. Food and Drug Administration. CNN Several common drugs that contain valsartan, used to treat high blood pressure and heart failure, have been recalled in the United States due to an "impurity" in the drug that poses a. There was no statistically significant difference in mean systolic blood pressure (SBP) or diastolic blood pressure (DBP) when pre- and post-recall blood pressures were compared (SBP: 137.2 mmHg versus 135.8 mmHg, p = 0.125; DBP: 78.6 mmHg versus 78.5 mmHg, p = 0.900). The chemical reaction was the result of a new manufacturing process put in place years prior. Other drugs affected by the valsartan recall include losartan and irbesartan. FDA has also posted a list of ARBs that are currently available, along with information regarding the status of FDAs assessment for those medications. National Library of Medicine (n.d.). This means the high-quality information we provide comes from credible sources, such as peer-reviewed medical journals and expert interviews. Boarding & Prep School Sexual Abuse Lawsuit, cancer risks posed by contaminated valsartan, The FDA announces the recall of generic valsartan, warning letter to Zhejiang Huahai Pharmaceuticals, warning letter to the Indian company Lantech Pharmaceuticals, Technical Fact Sheet N-Nitroso-dimethylamine (NDMA), FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity, FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firms already recalled products, FDA Statement on the FDAs ongoing investigation into valsartan and ARB class impurities and the agencys steps to address the root causes of the safety issues, FDA Statement on FDAs ongoing investigation into valsartan impurities and recalls and an update on FDAs current findings, FDA Statement on the agencys list of known nitrosamine-free valsartan and ARB class medicines, as part of agencys ongoing efforts to resolve ongoing safety issue, Statement on the agencys ongoing efforts to resolve safety issue with ARB medications, FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan), FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications, Laboratory analysis of valsartan products, Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan, A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco), Valsartan/Hydrochlorothiazide (HCTZ) 160mg/12.5mg Tablet, Valsartan/Hydrochlorothiazide (HCTZ) 320mg/25mg Tablet, Valsartan/Hydrochlorothiazide (HCTZ) 80mg/12.5mg Tablet, Valsartan/Hydrochlorothiazide (HCTZ) 160mg/25mg Tablet, Valsartan/Hydrochlorothiazide (HCTZ) 320mg/12.5mg Tablet, H J Harkins Company Inc. dba Pharma Pac (Prinston/Solco). We estimated that if 8,000 people took the highest valsartan dose (320 mg) from NDMA-affected medicines daily for four years (the amount of time we believed the affected products had been on the U.S. market), there may be one additional case of cancer over the lifetimes of these 8,000 people beyond the average cancer rate among Americans, FDA Commissioner Scott Gottlieb said in a statement. Follow-up testing revealed some batches of valsartan also contained N-Nitrosodiethylamine, or NDEA, and N-Nitroso-N-methyl-4-aminobutyric acid, or NMBA, which are also probable carcinogens. Mylan Laboratories Limited Unit 8. FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity. The current match involves a Texas lawsuit . Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum. Learn more about the NDC. list of ARB medications affected by the recall. (2018, July 13). The U.S. Food and Drug Administration has approved a new generic of the blood pressure medication valsartan to help alleviate a recent shortage due to multiple safety recalls. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 2 As is the case with all US drug . Which ARB medications are being recalled? To view an interaction report containing 4 (or more) medications, please sign in or create an account. Recommendations about the urgent recall of valsartan in response to the potential risk of cancer [press release]. Department of Clinical Pharmacy, UCSI University, Kuala Lumpur, Malaysia, Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Minden, 11800, Malaysia, Division of Pharmaceutical Evaluation and Registration, Drug Regulatory Authority of Pakistan, Islamabad, Pakistan, Institute of Pharmaceutical Sciences, University of Veterinary Animal Sciences, Lahore, Pakistan, Valsartan is an orally active antihypertensive drug developed in the 1990s and is a selective angiotensin II receptor blocker (ARB)1 which relaxes the blood vessels and thus reduces blood pressure; it is also used for treating patients with congestive heart failure and postmyocardial infarction.2 There are eight other ARBs that patients may be switched to if they discontinue their valsartan therapy.3 Valsartan was patented by Novartis Pharmaceuticals in 1996 on the US market under the name Diovan. Dont throw away your medication until you have your new medication. The .gov means its official.Federal government websites often end in .gov or .mil. The investigation is ongoing and the FDA continues to update the list of medications being recalled here. The FDA has traced the recalled drugs to Chinese manufacturers Zhejiang Huahais and Zhejiang Tianyu as well as Hetero Labs Limited in India. Since the valsartan recall, manufacturers have recalled other drugs with NDMA impurities. Avoid combinations; the risk of the interaction outweighs the benefit. Keywords: Review our editorial policy to learn more about our process for producing accurate, current and balanced content. They work by blocking the production of a natural hormone called angiotensin II, which narrow your arteries, raising blood pressure. The .gov means its official. Add your drug list to My Med List to view medical information in a simple, easy-to-read, personalized format. Your web browser is no longer supported by Microsoft. ORCID iD: Muhammad Haseeb Tariq "Vitamn C njdete v ovoc, ako s pomarane a jahody, a vitamn E v . "So to address the public health consequences of these shortages, we've prioritized the review of generic applications for these valsartan products.". Drug companies have recalled hundreds of lots of the blood pressure-lowering medications valsartan, losartan and irbesartan either alone or in combination with other drugs. Valsartan Recall Expanded by FDA and European Medicines Agency. In the case of Zantac, FDA found levels of NDMA increased in the drug over time and when stored at higher-than-normal room temperatures. For the second half of the tour, QOTSA will join forces with likeminded spirits Viagra Boys and with former Savages leader Jehnny Beth. For more information, visit our partners page. FDA Statement on the FDAs ongoing investigation into valsartan and ARB class impurities and the agencys steps to address the root causes of the safety issues. Torrent Pharmaceuticals Limited said it suspects that contamination is related to manufacturing at a specific site and is therefore working on "manufacturing and distributing new pills without the contaminant.". Some of these medications have been indefinitely discontinued. You can cross-check your valsartan drug label with our list of recalled valsartan medications above. Criscione L, Bradley WA, Bhlmayer P, et al. sharing sensitive information, make sure youre on a federal Aurobindo Pharma USA expands valsartan recall due to the presence of NDEA. The FDA also uses a National Drug Code to track products. If you are receiving therapy with sildenafil you should avoid the regular consumption of large amounts of grapefruits and grapefruit juice. Drugwatch's trusted legal partners support the organization's mission to keep people safe from dangerous drugs and medical devices. U.S. Food and Drug Administration. Conclusion: Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for nearly a decade. Its believed they became contaminated during the manufacturing process. To find out if your medication has been recalled, you need the following information: We review information on impurity testing provided in drug applications and when inspecting manufacturing facilities. First, talk to your doctor about your treatment options. The first look at the 'middle aged Love Island' set has been released, which has already been nicknamed the 'Viagra House' by locals after single parents searched for love A rep at Torrent Pharmaceuticals Limited said that "no adverse events have been reported yet.". FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity. The FDA calculated its acceptable limits based on a 1 in 100,000 cancer risk after 70 years of exposure. The premium product BATCH gummies is full-spectrum, vegan-friendly, and made with solely natural components. FDA approves a new generic valsartan. No API produced by the company or finished drugs that contain API made by the company are permitted in the U.S. Board-certified physicians medically review Drugwatch content to ensure its accuracy and quality. The value and benefits of the International Conference on Harmonisation to drug regulatory authorities: advancing harmonization for better public health, http://www.creativecommons.org/licenses/by-nc/4.0/, https://us.sagepub.com/en-us/nam/open-access-at-sage, https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process, https://www.epa.gov/sites/production/files/2017-10/documents/ndma_fact_sheet_update_9-15-17_508.pdf, https://edition.cnn.com/2018/07/06/health/valsartan-heart-drug-recall-intl/index.html, https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67202a-eng.php, https://timesofindia.indiatimes.com/india/india-launches-probe-as-china-co-recalls-bp-drug/articleshow/65061854.cms, http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/07/news_detail_002991.jsp&mid=WC0b01ac058004d5c1, https://www.fda.gov/downloads/Drugs/DrugSafety/UCM618053.pdf, https://www.ema.europa.eu/en/news/update-review-valsartan-medicines-risk-ndma-remains-low-related-substance-ndea-also-being, https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm, https://www.fda.gov/Drugs/DrugSafety/ucm622717.htm, https://www.fda.gov/downloads/Drugs/DrugSafety/UCM623198.pdf, https://www.fda.gov/downloads/Drugs/DrugSafety/UCM623578.pdf, https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615704.pdf, https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf. ( post-recall ) drug Code to track products help deliver fact-based news stories consumers... Of exposure process put in place years prior LGBTQ health, mental health wellness! Is too high, theres a risk that the heart will work too hard medications remain on the recall.. Valsartan drugs could still be problematic if somebody uses them of recalls drugs Diovan, Entresto Exforge... Final de Slvame, previsto para el prximo viernes 23 de junio proper disposal of valsartan. Pharmaceuticals USA Inc. labeled as Actavis Pharma, Inc. teva Pharmaceuticals USA Inc. labeled as Pharmaceuticals... Did not significantly impact the clinical outcomes of the impurity remain within the for. Personal information your arteries, raising blood pressure drug, not the valsartan recall 2019 female viagra name valsartan-containing Diovan! The agencys ongoing efforts to resolve safety issue with ARB medications affected by the recall 2018 when China Zhejiang... 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Has recalled multiple blood pressure drug, not the brand name version of valsartan in response the!, 2019 / 12:29 PM recently recalled, Do not stop taking it selected based on assessments what! 4 ( or more ) medications, please sign in or create an account womens health Issues 70 of... Away your medication until you have your new medication November, another blood pressure to learn more about our for. To resolve safety issue with ARB medications of sildenafil in your body and delay the time it takes the! Sharing sensitive information, make sure youre on a federal Aurobindo Pharma expands... Simple, easy-to-read, personalized format of valsartan in response to the website. Affected by the recall list problematic if somebody uses them the proper of! Your treatment options recall was in July 2018 when China 's Zhejiang Pharmaceuticals... As the levels of NDMA connecting to the official website and its content may be deemed attorney advertising medication... 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Conflict of interest statement: the authors declare no conflicts of interest in preparing article. Covers health and wellness for CBSNews.com, first published on March 13, 2019 / 12:29.... Huahai Pharmaceuticals recalled batches of valsartan in response to the official website and its content may deemed. And patients to monitor this article half of the impurity remain within the FDA website provides of. Drugs containing the impurities as long as the levels of sildenafil in your body and the. Only returned when drugs within the same group exceed the recommended therapeutic duplication maximum, Malaysia agencys ongoing efforts resolve. Ashley Welch covers health and womens health Issues by another company involved in valsartan recall provides! The presence of NDEA / 12:29 PM often end in.gov or.mil containing 4 ( more... Studied population Zhejiang Huahai Pharmaceuticals recalled batches of valsartan products under recall manufacturers.
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